The Medicines (Exemption from Licences) (Ingredients) Order 1974

Further conditions

4.  The exemptions conferred by Article 2 or, as the case may be, Article 3 of this order shall not apply—

(a) if, and so long as, the licensing authority are of the opinion that in the interests of safety the said exemptions should not apply and if the licensing authority have, by notice in writing, so notified such person whose activities in relation to the medicinal product in question would have been exempt by virtue of the said exemptions but for the provisions of this paragraph, and so long as such notification has not been withdrawn by the licensing authority, or

(b) where a person whose activities in relation to the medicinal product in question would have been exempt by virtue of the exemptions conferred by Article 2 of this order but for the provisions of this paragraph or where a person who has notified the licensing authority in accordance with Article 3(2)(a) of this order, fails to comply with a request in writing from the licensing authority, within the time specified in such request, either to furnish the licensing authority with such particulars in writing relating to the activity in question as would be required if such person were making an application for the grant of a licence under Part II of the Act relating to such activity or to make an application such as is described in Article 3(2)(b) of this order, or

(c) where there has been a failure to inform the licensing authority that a material change of circumstances has occurred in relation to the particulars furnished in response to such request as is referred to in paragraph (b) of this Article or in the particulars contained in or furnished in connection with an application such as is described in Article 3(2)(b) of this order.